CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM

FDA 510(k)

FDA Class 1 ·Microbiology

BD DIRECTIGEN FLU A+B

FDA 510(k)

FDA Class 2 ·Microbiology

TRIO 300

FDA 510(k)

FDA Class 2 ·Physical Medicine

SILIMED NASAL L SHAPED IMPLANT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

YEAST-PALETTE TM

FDA 510(k)

FDA Class 1 ·Microbiology

SPECTROPHOTOMETER (MICROASSAY PLATE READERS)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN), CEFOTAXIME (GN), 0.5-64 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

DOHLMAN DOANE KERATOPROTHESIS

FDA 510(k)

FDA Class 2 ·Ophthalmic

LKB 2230 ROTARY ONE

FDA 510(k)

FDA Class 1 ·Pathology

TERUMO SENSIBEAD EIG HCG KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

Burn Resuscitation Decision Support System - Clinical (BRDSS-C)

FDA 510(k)

FDA Class 2 ·Anesthesiology

MAPS 10000

FDA 510(k)

FDA Class 2 ·Radiology

FROG (Filter Removal of Glass)

FDA 510(k)

FDA Class 2 ·General Hospital

BD Phoenix™ Automated Microbiology System

FDA 510(k)

FDA Class 2 ·Microbiology

MTF ALLOGRAFT ANCHOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WHITSOFT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SPECTACLE FRAME

FDA 510(k)

FDA Class 1 ·Ophthalmic

SPRAYGENIX CRYO ABLATION SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology